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Found 26 results

  1. Celiac.com 11/22/2017 - A team of physicians recently reported on the case of a 3-year-old Albanian girl who presented at their clinic with carpal spasms and hand paresthesia. The physicians include Atifete Ramosaj-Morina; A. Keka-Sylaj; V. Hasbahta; A. Baloku-Zejnullahu; M. Azemi; and R. Zunec. A physical exam showed the girl to be in good physical condition, with a body weight of 10.5 kg (10 percentile). She was suffering from carpal spasms and paresthesias of her extremities. Positive Chvostek and Trousseau signs indicated neuromuscular irritability. Blood tests showed severe hypocalcemia with a total serum calcium of 1.2 mmol/L (normal range 2.12 to 2.55 mmol/L), ionized calcium of 0.87 (normal range 1.11 to 1.30 mmol/L), and 24-hour urine calcium excretion of 9.16 mmol (normal range female The team screened the girl for celiac disease with antigliadin immunoglobulin A, anti-tissue transglutaminase, and anti-endomysial immunoglobulin A antibodies. All tests were positive. The girl underwent a duodenal biopsy, which showed lymphocyte infiltration, crypt hyperplasia, and villous atrophy compatible with celiac disease grade IIIb according to the Marsh classification. Following her celiac diagnosis, the team conducted human leukocyte antigen typing, which provided a definite diagnosis of celiac disease. She was started on a gluten-free diet. Apparently, the girl did not follow a gluten-free diet, which caused a recurrence of carpal spasms. At 7 years of age, the girl showed signs of delayed psychophysical development. Although hypocalcemia is not uncommon in people with celiac disease, it is rare for hypocalcemic carpal spasm to be the first manifestation of the disease. Because of this, the doctors urge other physicians to consider the possibility of celiac disease in patients with repeated carpal spasms that seem to resist easy treatment. They indicate that celiac disease should be considered even in the absence of gastrointestinal symptoms, since hypocalcemia and carpal spasm may appear as the first symptoms of celiac disease, even in young children. Source: J Med Case Reports. 2017;11(252)
  2. Celiac.com 04/07/2017 - If watching all those pints of Guinness being downed on St. Patrick's Day left you wishing that someone, somewhere in Ireland, would brew a tasty gluten-free stout, your wish has come true. The people at the 9 White Deer brewery have heard your whispered wishes and responded with Stag Saor. Ireland's first gluten-free stout, a beer that puts a fresh twist on the Emerald Isle's long stout-brewing tradition. Now, a gluten-free stout was not always part of the plan. Less than a year after found the 9 White Deer microbrewery, co-founder, Don O'Leary was diagnosed with a gluten intolerance. Rather than view this development as a setback, however, O'Leary and his partners used it as fuel to drive their business. Working with his partner, the former marine engineer, Gordon Lucey , O'Leary set about creating the company's first gluten-free brew. O'Leary says that developing Stag Saor "changed everything for the business." Their market research taught them that, while Ireland has a fairly high percentage of people with celiac disease, it has a relatively paltry number of gluten-free beers. Saor launched in 2015 and received a bronze medal at the 2016 Blás na hEireann awards, winning against traditional beers in a blind taste test. Offered a preview sip of the new stout, writer Kevin Kennedy, calls the beer "top quality... as good as if not better, than any bottled stout I've had in the past." The 9 White Deer brewery draws its name from a 6th Century fable, in which angels told the famous Irish Saint, Gobnait, that she would establish an Abbey and a church on a site where she found 9 White Deer. The sight is just down the road from the brewery, which now employs eight people, in Ballyvourney, Co. Cork. Source: Newstalk.com
  3. Celiac.com 03/16/2017 - When screening arthritis patients for celiac disease, should HLA be done before serology? During the past decades, an accumulating evidence shows a dramatic rise in the frequency of autoimmune diseases, including rheumatoid arthritis and gastrointestinal conditions, such as celiac disease. HLA genes have been shown to be strongly associated with numerous autoimmune diseases, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) and celiac disease. A team of researchers recently set out to assess the performance of celiac disease associated serology in face of a rheumatologic patient, when gluten enteropaty is suspected. The research team included Hakim Rahmoune, Nada Boutrid, Mounira Amrane, and Belkacem Bioud. They are variously affiliated with the Pediatrics Department and the Biochemistry Department of Setif University Hospital at Setif-1 University in Algeria. The main question they sought to answer was: Should HLA be done prior to the serology? Could unnecessary serial serological celiac disease screening in such rheumatology patient be avoided by performing an HLA typing, as a long-life marker of genetically celiac disease-susceptible patients? Serogenetic screening without the requirement for follow-up small bowel biopsies provides a flexible, cost-effective methodology that could be widely applied to obtain accurate estimates of the prevalence of celiac disease in large group studies. Source: International Journal of Celiac Disease, 2017, Vol. 5, No. 1, xx. DOI:10.12691/ijceliac disease-5-1-2
  4. Celiac.com 10/28/2016 - Researchers still don't know why some people develop celiac disease or gluten intolerance, but a number of studies have focused on factors including breast-feeding, dietary habits, the timing of the introduction of gluten and geographical origin. Sweden is a high-risk country for the development of celiac disease in early life, with rates in some areas approaching 2%, nearly double that of most population baseline levels. Carin Andrén Aronsson is a dietician and doctoral student at Sweden's Lund University. Her research, ahead of her public thesis defense, indicates that the amount of gluten matter more than breast-feeding or the timing of introduction of gluten as a trigger for celiac disease. This is one of the findings from several extensive studies of children with an increased genetic risk of celiac disease conducted by researchers at Lund University in Sweden. "Our findings indicate that the amount of gluten triggers the disease," says Aronsson. Her research team has also observed that the dietary habits among the children they studied vary from one country to another, and that "there are reasons to analyze the significance of this variation more closely," she added. All the research in Aronsson's thesis is based on small children born with an increased genetic risk of celiac disease. Some of her most important conclusions are: Swedish children who reported consuming more than 5 grams of gluten per day up to the age of two years had twice the risk of developing celiac disease compared to children who consumed a smaller amount, while children with celiac disease reported eating more gluten druing that period. The risk of developing the autoimmunity which gives rise to celiac disease was highest in Sweden compared to Finland, Germany and USA, which were also studied. There was no apparent connection between the duration of the period of breast-feeding and the risk of developing celiac disease. Further study could help explain why Swedish children develop celiac disease earlier than children in other countries. Source: Lund University
  5. Celiac.com 03/09/2012 - Subway stores in Oregon are in the process of rolling out gluten-free sandwich buns and gluten-free brownies as regular menu items statewide, according to Subway spokesperson Cathie Ericson. For millions of Americans who avoid gluten, due to celiac disease or gluten sensitivity, eating out can be a constant challenge. Having easy access to a safe, tasty, low-cost gluten-free sandwich is like the Holy Grail for some of those folks. For many, being able to grab a gluten-free Subway sandwich would be a major step toward vanquishing the challenges of eating gluten-free. Subway understands that being gluten-free "…really cuts down on fast-casual dining options, particularly sandwiches,” said Michele Shelley, Subway board member and owner. Many people were excited to read about Subway's early testing of gluten-free products in selected areas. Many were equally excited to hear about Subway's commitment to getting their gluten-free sandwich offerings right, from start to finish. For example, Subway’s wheat-free sandwich rolls and brownies are produced in a dedicated gluten-free facility and are individually packaged. Subway staffers are trained to prevent cross-contamination during the sandwich-making process. Moreover, a single employee will prepare a gluten-free sandwich order from start to finish. Other features to Subway's gluten-free process include single-use knives and eliminating contact between traditional sandwich rolls and other ingredients including meat, cheese and vegetables. Oregon is one of a handful of states where Subway first tested gluten-free products in selected areas. The current statewide roll out in Oregon comes after a successful test in Bend and Portland, Subway restaurants, and seems to signal Subway's desire to offer gluten-free menus to diners. “Subway is known for being a leader in healthy fare, and we are excited to embrace these gluten-free menu items for those who can benefit from them,” Shelley told reporters. Source: http://community.statesmanjournal.com/blogs/menumatters/2012/01/27/oregon-subways-add-gluten-free-menu-options/
  6. At the start of the 2016 academic year, Kent State University becomes the first university in the country to feature an entirely gluten-free dining hall on campus. Kent State restructured Prentice Café after administrators noticed that the number of students arriving on campus with gluten intolerance was rising each year. The new dining facility will meet the ever-increasing demand for gluten-free foods. An estimated 3 million Americans suffer from celiac disease, a genetic autoimmune disorder that affects the digestive process. When a person who has celiac disease consumes gluten, the individual’s immune system attacks the small intestine and inhibits the body’s ability to absorb important nutrients. Gluten is a protein found in wheat, rye and barley. It is essential for those with celiac disease and sensitivity to gluten to avoid products containing these ingredients. Some individuals who have not been diagnosed with an allergy or sensitivity to gluten also choose to restrict their gluten intake as a personal preference. Until recently, however, it has often been difficult to find suitable gluten-free food options, especially when dining away from home. Kent State aims to make college life easier for students who need or prefer gluten-free foods. At Prentice Café, all menu items are gluten-free. Although many campuses offer gluten-free products and some even offer gluten-free stations in their dining halls, Kent State is the first campus to offer an entire dining hall that is certified gluten-free. "Students’ needs have always been our top priority," said Rich Roldan, director of university dining services at Kent State. "Students have enough to worry about - they should not havve to worry about their food being safe to eat. It is important they can eat in a safe environment, which is why we decided to make Prentice Café a gluten-free dining location." Prentice Café earned certification from the Gluten-Free Food Services Certification Program, a food safety program offered through the Gluten Intolerance Group. The Gluten Intolerance Group is a nonprofit organization dedicated to empowering the gluten-free community through consumer support, advocacy and education. Although gluten intolerance has gained attention in recent years, it can still be challenging to address the needs of students who have celiac disease or sensitivity to gluten. One issue is students’ reluctance to self-identify as gluten intolerant. Students are sometimes self-conscious about special dietary needs and often prefer not to feel singled out when dining on campus. This was something administrators considered when developing Prentice Café. "It’s important for students who have celiac disease or gluten intolerance to be able to have a safe location where they can go and not have to worry," explained Megan Brzuski, Kent State’s dining services dietitian. "There are many different menu items and options available for students to choose from at Prentice Café." Anyone is welcome to dine at Prentice Café, which is open Monday through Thursday from 8 a.m. to 8 p.m. and on Fridays from 8 a.m. to 6 p.m. In addition to every item being gluten-free, the menu also features a variety of vegan and vegetarian dishes, as well as foods that support a healthy lifestyle. The café accepts meal plans, cash and credit cards. Prentice Café opened on Aug. 29, the first day of the fall semester. A grand opening celebration will be held on Sept. 7 from 11 a.m. to 1 p.m. Students, faculty, staff and all members of the Kent State community are invited to attend the event, which will include opportunities to sample items, as well as educational displays and prizes. The Gluten-Free Food Service Certification Program, a program of the Gluten Intolerance Group, is a proven model of established best practices for food service establishments offering gluten-free options. Certifications and protocols are customized to the specific needs of each food service establishment who works with the Gluten-Free Food Service Certification Program, including considered factors such as facility size, number of locations and the type of food establishment. For more information about the Gluten-Free Food Service Certification program, visit www.gffoodservice.org. For more information about Kent State’s Dining Services, visit www.kent.edu/dining.
  7. Celiac.com 04/04/2016 - Any one eager to try the first approved treatment for celiac disease might not have to wait much longer. Alba Therapeutics has announced that their celiac treatment, larazotide acetate, will enter the first Phase 3 clinical trials ever conducted in a celiac disease drug later this year. Lorazotide acetate works by improving regulation of tight junctions in the bowel. In healthy people, these junctions remain closed except to shed dead cells, but in patients with celiac disease, gluten keeps tight junctions open, triggering an inflammatory reaction that eventually destroys the intestinal villi, tiny, finger-like projections in the small intestine that are essential for nutrient absorption. Early research suggests larazotide acetate helps to keep the tight junctions closed when it's taken before a meal, thus stopping, or reducing the reaction and the resulting inflammation. Larazotide acetate recently completed during phase 2b clinical trials for efficacy, safety and tolerability in 342 patients with celiac disease. Those trials showed larazotide acetate to be safe and effective in a "real world setting" for celiac patients, according to Alba's website. The treatment is now headed to Phase 3 trials in "late 2016", and has received "fast track" designation from the Food and Drug Administration. Alba has announced that Innovate Biopharmaceuticals Inc. has licensed all of Alba Therapeutics' assets related to larazotide acetate, and that larazotide acetate has been renamed INN-202. If approved on schedule, INN-202 will become the first prescription medicine for treating celiac disease. Source: Allergic Living
  8. Celiac.com 05/06/2016 - For an indication of just how quickly gluten-free food products are revolutionizing the food and beverage industry across the globe, look no further than the United Arab Emirates (UAE). Citizens of the UAE have high rates of diabetes. In fact, UAE ranks in the 10 top countries worldwide for the percentage of adults with diabetes. Other auto-immune conditions, such as celiac disease are also on the rise. Enter Tawa Bakery, the UAE's first dedicated gluten-free bakery which has opened on the Al Muneera Development at Al Raha Beach in Abu Dhabi, the UAE capital. Tawa offers a completely new experience for food lovers in the UAE with its 100 percent gluten-free menu, specifically designed to provide good, healthy food for people with auto immune disorders such as celiac disease. Launched by Dubai-based Glee Hospitality Solutions, Tawa Bakery mirrors the rising popularity of gluten-free diets across the globe in general, and in the region, in particular. Tawa offers a wide selection of breads, sandwiches, healthy meals, super foods, cakes and pastry items, all made with quality, healthy, organic and gluten-free ingredients. According to Abdul Kader Saadi, the managing director at Glee Hospitality Solutions, "Tawa Bakery is truly 100 per cent gluten-free and uses only those gluten-free items and ingredients to avoid cross contamination, with breads and baked goods to cater to the health dietary requirements of people." Source: the-mea.co.uk
  9. Celiac.com 02/11/2016 - Kansas is wheat country, and like the rest of America, Kansans are generally not gluten-free. That means the food in their charity food pantries are not usually gluten-free. That means that, however hard it might be to maintain a gluten-free diet in Kansas, or anywhere else in America, it's that much harder to maintain a gluten-free diet if you're poor, or simply can't afford the prices. However, things have gotten a bit easier in Kansas recently, where the efforts of two dedicated mothers of children with food allergies have led to the first free food pantry in the nation dedicated to food for people with food allergies. After meeting at a local support group and realizing their common problems, Amy Goode and Emily Brown joined forces to meet their challenges in finding and affording specialty foods required for their kids' diets. Both women faced high food bills for staple foods needed for their kids' food sensitivities. Brown's older daughter, for example, suffered multiple food allergies, and could only tolerate hemp milk, which is priced at $15 a gallon, and is not covered by the government's WIC program. Both women, Brown said, were "struggling to pay for our alternative milks, and it was just overwhelming." Allergy-friendly and gluten-free foods typically cost two to four times more than comparable regular items. In both cases, the women were struggling to keep their kids healthy, as the alternative is often lines and suffering in the kids. Goode said, " I think people miss that aspect of it. It's not just about the food, but it's about the health." Their efforts to offer an alternative have resulted in the launch of the ReNewed Health Free Food Pantry in Overland Park, located in the New Haven Seventh Day Adventist Church at 8714 Antioch Road. The church dedicated space for the pantry just across the hall from a regular food pantry stocked with non-gluten-free products. ReNewed Health offers only options for those with food allergies along with standard nutrient-dense foods, such as beans. Much of the food is donated by manufacturers, stores and a gluten-free bakery, and all that's needed to use the pantry is a doctor's note or lab results showing you or your child has a medical need for the foods. The pantry is open on Wednesdays from 9:30 a.m. to noon. Kudos to these Kansas moms for turning their challenge into a success for other people facing the same problem. And kudos to starting America's first free food pantry for people with food allergies and celiac disease. Source: fox4kc.com
  10. Celiac.com 01/27/2015 - Gluten-free beer drinkers rejoice! The first completely dedicated gluten-free brewery in the UK will open in Scotland in 2015. Edinburgh-based Bellfield Brewery was founded by a group of friends, two of whom have celiac disease, and will be dedicated to the creation of naturally gluten-free beers. Even though there are a number of naturally gluten-free, and some gluten-removed beers, already on the market, the news will doubtless put smiles on the faces of beer-loving celiacs and people with gluten-sensitivity, who must avoid traditionally produced beers to remain healthy. Bellfield Brewery plans to widen the range of available gluten-free beers by producing a premium IPA, and eventually, a stout, lager, with other beers to follow. To accomplish their goal, Bellfield’s owners are currently working with a number of master brewers in Scotland to develop new gluten-free recipes. Bellfield will debut its first products by summer 2015. What do you think? Do we need more and better gluten-free beers? Are you game for a gluten-free IPA?
  11. Celiac.com 02/04/2015 - For kids with a predisposition to celiac disease, does the age at which they first eat gluten have any connection with their risk for celiac disease? A team of researchers wanted to figure out whether the age at which a child first eats gluten carried any associated with risk for celiac disease, for genetically predisposed children. The Environmental Determinants of Diabetes in the Young (TEDDY) is a prospective birth cohort study. The research team included Carin Andrén Aronsson, MSca, Hye-Seung Lee, PhD, Edwin Liu, MD, PhD, Ulla Uusitalo, PhD, Sandra Hummel, PhD, Jimin Yang, PhD, RD, Michael Hummel, MD, PhD, Marian Rewers, MD, PhD, Jin-Xiong She, PhD, Olli Simell, MD, PhD, Jorma Toppari, MD, PhD, Anette-G. Ziegler, MD, PhD, Jeffrey Krischer, PhD, Suvi M. Virtanen, MD, PhD, Jill M. Norris, MPH, PhD, and Daniel Agardh, MD, PhD, for the The Environmental Determinants of Diabetes in the Young (TEDDY) Study Group. They are variously affiliated with the Department of Clinical Sciences, Lund University, Malmö, Sweden; the Pediatrics Epidemiology Center at the Department of Pediatrics of the Morsani College of Medicine at University of South Florida in Tampa, Florida; the Digestive Health Institute at the University of Colorado, Children’s Hospital Colorado in Denver; the Barbara Davis Center for Childhood Diabetes at the University of Colorado in Aurora, Colorado; the Department of Epidemiology, Colorado School of Public Health, University of Colorado at Denver in Aurora, Colorado; the Institute of Diabetes Research, Helmholtz Zentrum München, and Klinikum rechts der Isar, Technische Universität München, and Forschergruppe Diabetes e.V., Neuherberg, Germany; The Center for Biotechnology and Genomic Medicine, Medical College of Georgia, Georgia Regents University, Augusta, Georgia; Department of Pediatrics, Turku University Hospital, Turku, Finland; the Department of Physiology and Pediatrics, University of Turku, Turku, Finland; the National Institutes for Health and Welfare, Nutrition Unit, Helsinki, Finland; the School of Health Sciences, University of Tampere, Tampere, Finland; and the Research Center for Child Health at Tampere University and University Hospital and the Science Center of Pirkanmaa Hospital District, Tampere, Finland. For their study, the team followed up on 6,436 newborn infants who had been screened for high-risk HLA-genotypes for celiac disease in Finland, Germany, Sweden, and the United States. At clinical visits every third month, the team collected information about infant feeding. The first outcome was persistent positive for tissue transglutaminase autoantibodies (tTGA), the marker for celiac disease. The second outcome was celiac disease, defined as either a diagnosis based on intestinal biopsy results, or as persistently high levels of tTGA. The team found that Swedish children consumed their first gluten at an earlier age, 21.7 weeks on average, compared with 26.1 weeks for children from Finland, and just over 30 weeks for kids from Germany, and the United States (P < .0001). Over about a follow-up period ranging from 1.7–8.8 years, but averaging about five years, the team found that 773 (12%) children developed tTGA and 307 (5%) developed celiac disease. Compared with US children, Swedish children saw an increased risk for tTGA, with a hazard ratio of 1.74 [95% CI: 1.47–2.06]) and celiac disease, with a hazard ratio of 1.76 [95% CI: 1.34–2.24]), respectively (P < .0001). Gluten introduction before kids turn 17 weeks or after 26 weeks was not associated with increased risk for tTGA or celiac disease, adjusted for country, HLA, gender, and family history of celiac disease, neither in the overall analysis nor on a country-level comparison. TEDDY, is one of several recent studies that confirm that the age at first gluten introduction was not an independent risk factor for developing celiac disease. Source: Pediatrics; January 19, 2015. doi: 10.1542/peds.2014-1787
  12. Celiac.com 02/16/2015 - Celiac is predominantly a disease of the small intestine characterized by chronic malabsorption in genetically susceptible individuals who ingest grains containing. gluten, such as wheat, barley, and rye. Using strain and strain rate echocardiography imaging, a research team set out to assess left ventricular function in patients with celiac disease. The research team included S. Cenk, D.B. Aylin, A. Fatma Ebru, A.B. Nihal, Ö.S. Sevil, B. Serdal, B. Emine, A. Hüseyin, K. Telat, D. Tahir, E. Osman, and B. Engin. For their study, the team included twenty celiac patients and twenty healthy control subjects. They assessed left ventricle systolic and diastolic functions using standard 2-dimension, M-mode, conventional Doppler echocardiography. They obtained strain and strain rate parameters for 8 segments of the left ventricle. They found no significant differences between patients and controls regarding left ventricle function as assessed by 2-dimensional, M-mode, conventional Doppler. Initially, differences between strain rate values did not reach statistical significance, but when strain and average strain values were considered together, statistically significant differences emerged between the groups. For the first time a research team has been able to determine the subclinical effect of celiac disease on left ventricular systolic function by using strain echocardiography imaging. Their success shows the potential value of assessing cardiac involvement in celiac patients using these echocardiographic techniques. Source: Turk J Med Sci. 2014;44(2):173-7.
  13. Celiac.com 11/03/2014 - Some data have suggested that introducing gluten to infants at 4 to 6 months of age can help to lower the risk of celiac disease. To get a clearer picture of any potential benefits of introducing gluten within this time period, a team of researchers performed a multi-center, randomized, double-blind, placebo-controlled dietary-intervention study. The research team included Sabine L. Vriezinga, M.D., Renata Auricchio, M.D., Enzo Bravi, M.S., Gemma Castillejo, M.D., Anna Chmielewska, M.D., Ph.D., Paula Crespo Escobar, B.Sc., Sanja KolaÄek, M.D., Ph.D., Sibylle Koletzko, M.D., Ph.D., Ilma R. Korponay-Szabo, M.D., Ph.D., Eckart Mummert, Ph.D., Isabel Polanco, M.D., Ph.D., Hein Putter, Ph.D., Carmen Ribes-Koninckx, M.D., Ph.D., Raanan Shamir, M.D., Ph.D., Hania Szajewska, M.D., Ph.D., Katharina Werkstetter, M.Sc., M.P.H., Luigi Greco, M.D., Ph.D., Judit Gyimesi, M.D., Corina Hartman, M.D., Caroline Hogen Esch, M.D., Ph.D., Erica Hopman, R.D., Ph.D., Anneli Ivarsson, M.D., Ph.D., Tunde Koltai, Ir., Frits Koning, Ph.D., Eva Martinez-Ojinaga, M.D., Chantal te Marvelde, B.Sc., Ana Pavic, M.D., Jihane Romanos, Ph.D., Els Stoopman, Vincenzo Villanacci, M.D., Ph.D., Cisca Wijmenga, Ph.D., Ricardo Troncone, M.D., Ph.D., and M. Luisa Mearin, M.D., Ph.D. For their study, the team recruited 944 children who were positive for HLA-DQ2 or HLA-DQ8, with at least one first-degree relative with celiac disease. From 16 to 24 weeks of age, 475 participants received 100 mg of immunologically active gluten daily, and 469 received placebo. The team then made periodic measurements of anti–transglutaminase type 2 and antigliadin antibodies. The overall goal was to determine the frequency of biopsy-confirmed celiac disease at 3 years of age. The team confirmed celiac disease through biopsy in 77 children, while three more received a celiac diagnosis of based on the 2012 European Society for Pediatric Gastroenterology, Hepatology, and Nutrition diagnostic criteria for a total of 80 celiac children. The cumulative incidence of celiac disease among patients 3 years of age was 5.2% (95% confidence interval [CI], 3.6 to 6.8), with similar rates in the gluten group and the placebo group (5.9% [95% CI, 3.7 to 8.1] and 4.5% [95% CI, 2.5 to 6.5], respectively; hazard ratio in the gluten group, 1.23; 95% CI, 0.79 to 1.91). Both groups also showed similar rates of elevated levels of anti–transglutaminase type 2 and antigliadin antibodies (7.0% [95% CI, 4.7 to 9.4] in the gluten group and 5.7% [95% CI, 3.5 to 7.9] in the placebo group; hazard ratio, 1.14; 95% CI, 0.76 to 1.73). The team also noted that breast-feeding, regardless of whether it was exclusive or whether it was ongoing during gluten introduction, had no substantial impact on the later development of celiac disease. Compared to the placebo, introducing small quantities of gluten to high-risk children at 16 to 24 weeks of age had no impact on rates of celiac disease at 3 years of age. So, basically, the data show that there is no need for parents to fret or worry about when their child first begins to consume gluten. There is no magic window or timeframe for introducing gluten to their child’s diet that will change the risk for developing celiac disease later on. Source: N Engl J Med 2014; 371:1304-1315October 2, 2014. DOI: 10.1056/NEJMoa1404172
  14. Celiac.com 10/22/2013 - Yeah, you heard right. People who've been dreaming of the day the Girl Scouts would offer a gluten-free cookie can stop dreaming! That's because a select group of Girl Scout councils nationwide will be slinging the organization's very first gluten-free offering as part of the 2013-14 Cookie Sale. The new cookie, called the Gluten Free Chocolate Chip Shortbread cookie, is made with real chocolate chips and real butter, and contains no artificial flavors, no artificial colors, no high fructose corn syrup, no palm oil, and no hydrogenated oils. The gluten-free cookies will be sold in a 5 ounce resealable foil pouch, with 12 pouches per case. Click here for nutrition information for Gluten Free Chocolate Chip Shortbread Cookie. Click here for frequently asked questions regarding the new gluten free cookie. Click here for information on where you can buy the Girl Scouts' Gluten Free Chocolate Chip Shortbread Cookies.
  15. Hi, I'm 17 and have just started the gluten free diet. I am very excited to see results and just want to know; What were your earliest symptoms to go away and how long did it take?
  16. Celiac.com 10/20/2010 - U.S. doctors and patients looking for accurate early diagnosis of celiac disease now have a state of the art celiac disease assay with a high level of sensitivity and specificity. The US Food and Drug Administration (FDA) has given 510(k) clearance for the first two fully automated gliadin tests featuring deamidated peptides for celiac disease. Manufactured by Phadia US, the tests, EliA GliadinDP IgA and EliA GliadinDP IgG, are designed to be used in conjunct with other laboratory and clinical findings in the early diagnosis of celiac disease. According to Gabi Gross, autoimmune franchise leader for Phadia US, "EliA GliadinDP IgA and EliA GliadinDP IgG will offer physicians who suspect a possible case of celiac disease, antibody tests with the lowest number of false positive results." This means less "unnecessary endoscopies and biopsies," she adds. EliA GliadinDP IgA and EliA GliadinDP IgG will offer antibody tests with the lowest number of false positive results for doctors who suspect a patient has celiac disease. The assays are optional on Laboratory Systems Phadia 100Є and Phadia 250 instruments with features like quick turnaround, monthly calibration, onboard instrument dilution, and a discrete single-well, random-access, nonmicrotiter plate format. Phadia also manufactures other approved CLIA moderately complex assays in the EliA autoimmune product line, including anticardiolipin IgG/IgM, anti-B2-glycoprotein 1 IgG/IgM, cyclic citrullinated peptide, tissue transglutaminase IgA/ IgG, gliadin IgA/IgG, dsDNA, antinuclear antibody screen, and ENA antibodies to the following antigens: Sm, U1RNP, RNP70, Ro, La, Scl-70, CENP, and Jo-1. Source: Medscape
  17. Celiac.com 05/25/2004 - On April 27, 2004, for the first time, individuals with Celiac Disease testified before a Congressional Committee. Lisa Murphy, and her son, Colin, represented the ACTF before the House Appropriations Subcommittee on Labor, HHS, and Education. They did an outstanding job outlining what celiac disease is, who it affects, the need for NIDDK to develop a research plan for celiac disease, as well as the need for greater physician and patient education (The Murphy family, of Chappaqua, NY, was featured in a Feb. 2004 Parents magazine article about celiac disease). The Labor-HHS Subcommittee determines how much money NIH receives each year. Having individuals with Celiac Disease provide information about the disease is critical to securing funding for research. After hearing the testimony, Subcommittee Chairman, Ralph Regula (R-OH), asked if food labels were a problem for celiacs. Not missing a beat, Lisa offered an emphatic, Yes, then highlighted problems she has encountered. Rep. Nita Lowey (D-NY), sponsor of H.R. 3684, the Food Allergen Labeling and Consumer Protection Act, and member of the Subcommittee, explained the bill was drafted to help individuals like Lisa, and Colin. The celiac community has waited a very long time for this incredible opportunity. The American Celiac Task Force is grateful to the entire Murphy family for graciously agreeing toshare their story, and for helping to make this historic day possible. Allison Herwitt Co-Chair, Legislative Project American Celiac Task Force
  18. Celiac.com 04/06/2009 - Celiac sufferers around the globe are anxiously awaiting word from Australia, as the world's first vaccine trials for the treatment of celiac disease get underway in Melbourne. In April, Bob Anderson, of the Walter and Eliza Hall Institute of Medical research, will begin the initial phase of the first-ever trials for a celiac vaccine that, if successful, might just mean the end of gluten-free diets for those with celiac disease. The treatment has been successful in mice and is now ready to be tested on humans. In this initial phase, 40 volunteers with celiac disease will receive doses of the vaccine over an 11-month period to determine that it will cause no harm. Once researchers make sure the vaccine is safe, they will begin phase II trial, wherein they give vaccine doses to trial subjects and evaluate their responses to gluten challenges to determine the efficacy of the vaccine. Evaluation will include an examination of immune response and intestinal condition to determine the level of gluten tolerance. The vaccine therapy involves repeatedly injecting solutions of gluten at increasing concentrations. The goal is to reduce and ultimately eliminate gluten sensitivity slowly, in a manner similar to common allergy desensitization treatments. The road to the development of this treatment has not been easy. Dr. Anderson is that rare combination of medical doctor (gastroenterologist) and PhD scientist who is able to develop practical treatments from bedside observations. After struggling to gain funding throughout his research career, he eventually patented his vaccine and co-founded Nexpep in an effort to develop the vaccine on his own. Because, like common dust and hay fever allergy therapies, this treatment approach may allow people with celiac disease to actually consume the gluten that produces the toxic reaction and reduce or even eliminate that reaction via vaccination. This approach will also serve as a model for a vaccine approach for other immune conditions such as type 1 diabetes, rheumatoid arthritis and multiple sclerosis. Until recently, doctors thought celiac disease was rare. But according to statistics, it is twice as common as type1 diabetes or breast cancer. Celiac disease is now known to strike one per cent of Americans, but although modern blood testing has made early detection accurate and efficient, most people with celiac disease still do not know that they have it. Just 3% of sufferers have been diagnosed, leaving nearly 3 million people undiagnosed, and therefore unable to benefit form simple treatment in the form of a gluten-free diet. Long-term risks for untreated celiac disease include malnutrition, infertility, osteoporotic fractures, liver failure and various cancers. Symptoms can vary between individuals, with some experiencing no symptoms at all, even though damage to the bowel and general health still occurs whether or not symptoms are present. Presently, long-term monitoring of dietary compliance for celiac patients is haphazard at best, and standards for gluten-free products have yet to take effect in the USA and other countries. Geoff Withers, director of pediatric gastroenterology at Brisbane's Royal Children's Hospital, points out that a gluten-free diet is "notoriously difficult. It is expensive and lifelong, and comes at a cost to the individual." Even treatment with a gluten-free disease is no panacea. People on gluten-free diets routinely suffer from a deficiency of certain vitamins, especially B vitamins. Roughly half of those following gluten-free diets have impaired intestinal healing due to compliance issues, and that means they are in danger of associated risks which include cancer. A successful vaccine could have massive consequences for treatment of celiac disease, and might radically improve the lives of those with the condition.
  19. Celiac.com 08/24/2011 - By all accounts, the first ever D.C. Gluten-free Expo, which recently wrapped up, was a success for sponsors, vendors and consumers of gluten-free foods. The event attracted more than 60 vendors of gluten-free products ranging from pizza, breads and baked goods to cereals, specialty mixes, and other prepared foods. More than 600 people attended the exhibit hall at the Embassy Suites Convention Center in downtown D.C. The hall was packed with gluten-free products, many offered up for tasting. Expo proceeds from the $10 public admission price, and the $75 “Globally Gluten-Free” cocktail reception at Finn & Porter afterward, helped to raise more than $20,000 for expo host and sponsor, The Celiac Disease Program at Children’s National Medical Center. The reception boasted a fine gluten-free spread, including a selection of gluten-free pastas, along with Bready brand breads. An equally generous Mexican selection offered corn tortillas and a wide range of vegetables, and was complemented by a selection of lamb and chicken skewers, hummus, and a sweet potato mash. The next D.C. Gluten-free Expo is scheduled for June 15, 2012.
  20. Nutritionist Melissa Diane Smith, author of Going Against the Grain, has written a new book, Gluten Free Throughout the Year: A Two-Year, Month-to-Month Guide for Healthy Eating. I’m happy that today we at Celiac.com have the exclusive first interview with Melissa about her book. Scott: Hi Melissa, thank you for stopping by to answer my questions about your new book. I think this is a book that will interest many Celiac.com readers and we’re delighted to have you here. Melissa: I am delighted to be here. I really admire the work you do on this site and I’m thrilled to have Celiac.com be the first place to begin spreading the word about my new book. Q: Let’s start with this question: What was your primary goal in writing Gluten Free Throughout the Year? A: My primary goal was to help people learn how to eat gluten free and healthy so that they can experience improved health and protect themselves against disease. If you stop and think about it, improving and protecting our health is the reason all of us began eating gluten free in the first place. We all know that it’s quite a challenge to go from the diet that most of us were used to eating, to avoiding all sources of gluten in our diet. Because of that, many of us focus on gluten free and nothing else, either not knowing or just plain ignoring basic rules of nutrition that could keep us healthy. By doing that, we often end up getting brand new health problems, including unintended weight gain or blood-sugar- or insulin-related health problems such as diabetes or prediabetes. Many people think “Eating gluten free is so hard, I can’t make any more improvements to my diet.” But in my book, I wanted to show people that it’s not as difficult as they think. You can live the gluten-free lifestyle you’re currently living and gradually learn how to make better food choices that are very tasty and that keep you healthier over the long term. Q: You have organized the information in your book in an interesting way. Can you tell our readers about the format in the book and how that came to be? A: The chapters in the book are organized in a month-to-month format and cover seasonal topics or common issues that gluten-free eaters run into. The chapters are short, easy to read, and packed with practical tips. With this format, people who don’t have much time can quickly grasp the main concepts that are covered and how to apply them in their gluten-free life. That format came to me in large part because after the publication of my Going Against the Grain book in 2002, I held in-person Going Against the Grain Group monthly support meetings for six and a half years. From those meetings, I came to understand the issues and seasonal topics most people had questions about and wanted the most help with at various times of year. I also came to understand that people couldn’t learn everything about nutrition all at once. People need time to learn how to eat gluten free and to improve their diet in other ways. They need time to learn helpful nutrition information, to have it soak into their minds, to learn how to choose tasty but higher-quality gluten-free foods, and how to combine gluten-free foods in simple yet delicious ways. Because we’re all busy, most of us learn in bits and pieces, and what we learn first is usually based on what is most timely, applicable or helpful to us right now. So, the book is organized as a handbook to help you eat better no matter what time of year it is. You can flip to the March chapter (“Spring-Clean Your Diet”), to July (“Eating Out in Restaurants”), to September (“Gluten-Free School Days!”), to December (“How to Have a Healthier Holiday Season”), depending on the information you need at the time. Q: In your book you indicated that consumers seem to know how to manage their symptoms of gluten sensitivity, regardless of the fact that most doctors are still clueless. Why do you think doctors are so behind times with this vastly growing epidemic? A: Many doctors are so busy in their everyday practices that they simply don’t have time to stay up to date on the latest research. Most doctors who now practice medicine were taught in medical school that the only gluten-related disease was celiac disease and that it was very rare and only showed itself with severe gastrointestinal symptoms, such as diarrhea, malabsorption and weight loss. That’s what doctors look for, if they’re looking for gluten-related illness at all. We now know that all of that “information” is out of date. We also know that gluten sensitivity is a bona fide medical condition that affects far more people than celiac disease and provokes an astounding array of symptoms, but most people with non-celiac gluten sensitivity simply aren’t diagnosed with it and needlessly suffer from unwanted, uncomfortable symptoms. Without adequate help from doctors who understand gluten sensitivity, more and more people who were told they didn’t have celiac disease started taking matters into their own hands and began taking gluten out of their diets to relieve and eradicate their symptoms. Going gluten free helped many people when modern medicine didn’t and couldn’t. When people go a bit further and eat gluten free and healthy, they can take their health to a whole new level. Q: In your book you suggest that a gluten free diet can be harmful if done incorrectly. What do you mean by this? A: Far too many people who avoid gluten for their health eat foods that are made with disease-causing processed ingredients, including refined flours (such as white rice flour), refined sugars (such as sugar or evaporated cane juice), and refined fats (such as soybean oil, corn oil, and partially hydrogenated oil). Refined flours, sugars and fats don’t cause illness in the same way that gluten does, but they interfere with healthy blood sugar metabolism and fatty acid metabolism and set the stage for degenerative diseases to develop and worsen over time. Overall, many people who eat gluten free are so focused on avoiding gluten that they often don’t concentrate on selecting healthy sources of carbohydrates, fat, and protein, and foods rich in vitamins and minerals. That takes its toll on health in the long term in a different way than what gluten was doing to them. Earlier this spring many people saw Jamie Oliver’s Food Revolution TV show, which focused on teaching people that they need to avoid junky processed foods and eat more fresh foods, especially more vegetables, to lose weight and improve their health. Well, we need a food revolution in the gluten-free community. We need to realize that we are not immune to the negative health effects of junky processed foods, even if those foods are gluten free, and we need to bring more fresh, nutritious, whole foods into our diets. That’s what my book is all about. Q: What do you think is the biggest mistake people make when initiating a gluten-free diet? A: The biggest mistake by far is trying to eat what most people in the United States eat but just make it gluten free. The United States is the fattest nation on Earth. We shouldn’t want to emulate the Standard American Diet, appropriately abbreviated SAD, with all its pizza, pasta, bread, baked goods, desserts and snack foods. It’s not a healthy diet. It spikes blood sugar levels, which spikes insulin levels, which sets off a cascade of events to occur in the body that promote unhealthy weight gain and numerous heart disease risk factors to develop. You can switch to pizza, pasta, bread, baked goods, desserts and snack foods that are all gluten free. By doing that, your immune system won’t be reacting to gluten. But, unfortunately, gluten-free versions of those foods still are high in blood-sugar-spiking carbohydrates, wreak havoc on blood sugar and hormonal systems in the body, and set off that same cascade of events to occur that lead in time to insulin-related conditions, including weight gain, type 2 diabetes, heart-disease risk factors, and more. It’s great that we have so many gluten-free food options available today, and we can have substitutes for wheat-based foods occasionally. But all of us really need to cut down on grain products and sweets, select those that we eat more carefully, and eat more lower-carbohydrate, nutrient-rich, fresh vegetables and fruits. That is the answer to long-term weight control and good health that many people, including those who eat gluten free, miss. Q: What are some of the main issues and topics you cover in your book? A: Everything from gluten-free traveling and gluten-free parties, to the difference between lactose intolerance and a milk allergy, to the little-known troubles that people have with corn. I of course also cover the various seasons, such as in the chapters, Enjoying the Juicy Fruits of Summer and Celebrating Autumn’s Bounty. And I have a recipe or two at the end of every chapter. Q: Could you give us a little taste of some of the practical information you offer in your book? For example, we're getting to that time of year when people have outdoor picnics but some of us who eat gluten free get stuck as to what we can take on picnics. Can you name a few suggestions from your book? A: Sure. For a quick brown-bag type picnic, you can make sandwiches with meat leftovers or gluten-free deli meat on gluten-free bread, organic corn tortillas, or a lower-carbohydrate, grain-free tortilla substitute that is just now coming to market. Throw in some veggie sticks and fruit for a quick, well-balanced meal. Picnics also are a great time to use salads as main dishes, side dishes or desserts. You can make a main-dish salad with greens, assorted vegetables, nuts or seeds, and chilled cooked steak, chicken or fish. You can fix a nutrient-rich side dish using quinoa in place of couscous to make tabouli or iodine-rich Sea Tangle Kelp Noodles in place of rice pasta to make pasta salad. Or make the recipe in the book for Greek Potato Salad made with olive oil and lemon juice instead of soybean oil-based mayonnaise. For dessert, you can prepare a colorful assorted fruit salad such as blueberries, raspberries and sliced strawberries. Finally, you don’t have to take a big assortment of pre-made food. Sometimes the best picnics of all are spreads of finger food to nibble on, such as slices of cold pot roast or roast chicken or meat kabob pieces, garlic-stuffed olives, guacamole or salsa with organic blue corn chips or Mexican-style flax crackers, assorted nuts, and red or green grapes. These foods are fun to grab as needed in between good conversation or throwing a Frisbee or football back and forth. Q: Would you say the recipes in your book are different in any way from recipes in other books? And could you name a few of your recipes? A: My recipes are as no-fuss as possible and they’re also as nutritious as possible. Contrary to what many people think, eating food that is good for you does not need to involve a lot of work or deprivation. In fact, when you do it right, simply prepared food actually has a gourmet taste. My grandfather was a Greek chef and I love good, tasty food. A few of the recipes in the book are Dairy-Free Brown Rice Pudding, Almond Pancakes, Chestnut Stuffing, Pink Rice Pilaf with Roasted Asparagus and Mushrooms, and Chicken and Strawberry Salad with Cilantro-Lime Dressing. I even have the recipe for Quinoa Pancakes with Peanut Sauce that Dr. Rodney Ford, his wife Chris, and I shared at a local restaurant when they visited my hometown last year. In my recipes, common food allergens are avoided as much as possible, and the book mentions convenient, healthy, gluten-free food products to try by name. Scott: Your book is really unique, and informative. I loved the recipes and can't wait to try them! Thank you for stopping by and answering my questions, Melissa. Melissa: It was my pleasure. Thank you for having me.
  21. Celiac.com 08/20/2009 - For the first time, a team of celiac disease researchers has discovered a role for the main inherited celiac-associated genetic variation, connecting altered NF-kB signalling with risk variants associated with Celiac disease in TNFAIP3 and REL. The research team was made up of G. Trynka, A. Zhernakova, J. Romanos, L. Franke, K. A. Hunt, G. Turner, M. Bruinenberg, G. A. Heap, M. Platteel,1 A. W. Ryan, C. de Kovel, G. K. T. Holmes, P. D. Howdle, J. R. F. Walters, D. S. Sanders, C. J. J. Mulder, M. L. Mearin, W. H. M. Verbeek, V. Trimble, F. M. Stevens, D. Kelleher, D. Barisani, M. T. Bardella, R. McManus, D. A. van Heel, C. Wijmenga. An earlier celiac disease genome-wide association study (GWAS) identified risk variants in the human leucocyte antigen (HLA) region and eight new risk areas. To find more celiac disease locations, the research team chose to examine 458 single nucleotide polymorphisms (SNPs) that exhibited weaker ties in the GWAS for genotyping and analysis in four independent cohorts. The 458 SNPs were found among 1682 cases and 3258 controls from UK, Irish and Dutch populations. The team combined the results with the original GWAS cohort involving 767 UK cases and 1422 controls), in which six SNPs showed association with p,1610. Those six were then genotyped in an independent Italian celiac cohort (538 cases and 593 controls). The research team found two new celiac disease risk regions: 6q23.3 (OLIG3-TNFAIP3) and 2p16.1 (REL). In the final combined analysis of all 2987 cases and 5273 controls, both regions achieved genome-wide significance (rs2327832 p=1.3610, and rs842647 p=5.2610). The researchers used RNA isolated from biopsies and from whole blood RNA to look at gene expression. They observed no changes in either gene expression, or in the correlation of genotype with gene expression. From these results, the research team concluded that both TNFAIP3 (A20, at the protein level) and REL are key mediators in the nuclear factor kappa B (NF-kB) inflammatory signalling pathway. For the first time, researchers have identified a role for main inherited variation in this important biological pathway that predisposes individuals to celiac disease. Currently, the HLA risk factors and the 10 established non-HLA risk factors provide an explanation for about 40% of inheritance factors for celiac disease. Clearly, more research is needed to isolate the other 60% of inheritability factors for celiac disease. Success in this very important area promises to open up the understanding of celiac disease, and to help speed new treatments, and possibly a cure. Gut 2009;58:1078–1083.
  22. Celiac.com 12/27/2005 - Enjoy Life Natural Foods will begin displaying the GFCO certification mark on all 17 of their products beginning in December 2005. Enjoy Life has a strong commitment to the celiac community. We hear from consumers everyday, expressing how much difficulty they have identifying foods that are safe for their gluten-free diet, said Scott Mandell, President and CEO of Enjoy Life Natural Brands. We are proud to be able to provide them with the extra convenience and safety assurance this new certification provides. Look for more information about Enjoy Life Natural products and recipes using these products at www.gfco.org and www.enjoylifenb.com. Gluten-Free Certification Is HOT! The food industry is buzzing about gluten-free and GFCO. GFCO has attended five food shows and exhibits with a total of more than 1,000 food companies since August. GIG, Shelley Case, RD and Carol Fenster, Ph.D. gave talks about the gluten-free market at three of these shows. Before we hit the show room floor, the room was buzzing about gluten-free products and gluten-free certification. The Food Allergen Labeling & Consumer Protection Act (FALCPA) and data from SPINS showing that Gluten-free product sales are growing at 14.6 % is making gluten-free a high priority in the food industry. GFCO is drawing interest from mainstream and specialty companies alike. What Has Happened Since August: Plant Inspections for six companies will be scheduled for early 2006. 52 other companies have requested applications. Companies interested in adopting GFCO certification come from seven countries including Canada, China, Germany, Israel, Italy, South Africa, and the UK. GFCO has discussed the program with over 150 companies. Interested companies include makers of beverages, meat products, baked goods, nutritional supplements, flavorings, seasonings, and more. Want to Help? You Can Tell the GFCO about companies you think should certify their products. Tell companies that you want to see certification on their products. Support GIG and GFCO with your contributions and fundraising ideas. Join the GFCO Team Anna Ashworth Gluten-Free Certification Organization Program Administrator www.gfco.org
  23. Celiac.com 12/03/2007 - Along with the increasing rate of celiac disease diagnosis comes a corresponding increase in the need for safe, inexpensive, and appetizing gluten-free foods. Sorghum is inexpensive to grow, has a neutral flavor, and has been assumed to be gluten-free due to its close relationship with maize. Sorghum has been consumed in many parts of the world in foods and beverages such as flat breads, porridge, and beer. However, in the United States, the country that grows most of the world's sorghum, it is used primarily as animal feed. Researchers tested the safety of sorghum in duodenal biopsies (tissue samples from the small intestine) from 8 celiac patients and 4 patients with other gastrointestinal disorders (i.e., not celiac disease). Biopsies treated with sorghum protein digests showed no increase in proteins involved in the immune response to gluten. By comparison, biopsies of celiac patients treated with gliadin or wheat protein digests showed an increase in these proteins, as expected. The immune response was not induced in biopsies of non-celiac patients, regardless of treatment. In the second part of the study, the safety and palatability of sorghum foods were tested in 2 female celiac patients, known to be compliant with a gluten-free diet. The patients ate sorghum in bread, cookies, and cake for 5 days. Antibodies for transglutaminase, known to be elevated after gluten consumption in celiac patients, did not increase in the patients during or after the sorghum challenge. The celiac patients rated the palatability of the foods as good or excellent and reported no increase in gastrointestinal (GI) or non-GI symptoms. Researchers from Italy, the United Kingdom and the United States carried out this preliminary study. The data indicates that sorghum is highly likely to be safe for consumption by those who are gluten-intolerant. Additional studies are required to determine the long-term safety of sorghum in the diet of celiac patients. References: Ciacci, C. et al. (2007) Celiac disease: In vitro and in vivo safety and palatability of wheat-free sorghum food products. Clin. Nutr. 26, 799-805. U.S. Grains Council Web Site. Sorghum. Accessed Dec 1, 2007.
  24. Celiac.com 10/28/2005 - Alba Therapeutics Corporation (Alba) today announced successful completion of its first Phase I trial for the drug candidate AT-1001, and that the FDA has granted Fast Track designation to AT-1001 for treatment of celiac disease. We are pleased to have concluded our first human study of oral AT-1001 and delighted that the FDA has granted fast track status to AT-1001. These two events are important additional milestones in our efforts to help those suffering from celiac disease, a disease for which there is no effective treatment, said Blake Paterson, MD, President and CEO of Alba. Alba plans to begin a proof of concept study demonstrating efficacy of AT-1001 in celiac patients within the next few months. Fast track process is designed to facilitate development and expedite the review of new drugs with the potential to address significant unmet medical needs for the treatment of serious or life-threatening conditions. Potential fast track benefits include FDA input into development, submitting new drug applications in sections rather than all at once and the option of requesting Accelerated Approval. About Celiac Disease Celiac disease is a T-cell mediated auto-immune disease that occurs in genetically susceptible individuals and is characterized by small intestinal inflammation, injury and intolerance to gluten. Gluten is a mixture of proteins found in common food grains such as wheat, rye and barley. According to the NIH, celiac disease affects approximately 3 million Americans, although the diagnosis is rarely made. The only treatment for celiac disease is complete elimination of gluten from the diet, which results in remission for some patients. About Zonulin Zonulin is an endogenous signaling protein that transiently and reversibly opens the tight junctions (tj) between the cells of epithelial and endothelial tissues such as the intestinal mucosa, blood brain barrier and pulmonary epithelia. Discovered by Alba co-founder Dr. Alessio Fasano, zonulin appears to be involved in many disease states in which leakage occurs via paracellular transport across epithelial and endothelial tight junctions (tj), and thus may play an important potential role in the treatment of auto-immune diseases. About Alba Alba Therapeutics Corporation is a privately held biopharmaceutical company based in Baltimore, Maryland. Alba is dedicated to commercializing disease-modifying therapeutics and drug delivery adjuvants based on the zonulin pathway. Albas lead molecule, AT-1001, is targeted towards the treatment of Celiac Disease and Type 1 Diabetes. Contact: Dr. Blake Paterson Alba Therapeutics Corporation 410-522-8708
  25. - Genetic Digestive Disorder Affects an Estimated One in 250 Americans - Celiac.com 02/26/2003 - WOODLAND HILLS, Calif., Feb. 19, 2003/PRNewswire -- Results from a new study may lead to the first medical treatment for celiac disease, a hereditary digestive disease that can damage the small intestine and interfere with the absorption of nutrients from food. Celiac disease sufferers cannot tolerate gluten, a protein that is found in wheat, barley and rye. Celiac disease affects an estimated one in 250 Americans, mostly those of European descent, and there is no known medical treatment or cure. Zengen, Inc. researchers discovered that a synthetic form of alpha-Melanocyte-Stimulating Hormone (alpha-MSH) has an anti-inflammatory effect in celiac mucosa, the inside lining of the intestinal tract that absorbs food into the body. A naturally occurring molecule, alpha-MSH modulates inflammatory and immune responses. Data confirming the presence of alpha-MSH in celiac mucosa suggests the presence of a local reaction of the molecule to control the inflammatory response elicited by gliadin. Gliadin is the sub fraction of gluten that acts as a toxin or poison in people with celiac disease; it causes an immune reaction, resulting in damage to the small intestine and an inability to digest and absorb nutrients necessary for health and growth (malabsorption). The findings, Anti-Inflammatory Effects of alpha-Melanocyte-Stimulating Hormone in Celiac Intestinal Mucosa, appear in the February 20, 2003 issue of NeuroImmunoModulation, the official journal of the International Society for Neuroimmunomodulation. Our research suggests that locally-produced alpha-MSH modulates inflammation and perhaps limits epithelial damage in patients with celiac disease, stated James M. Lipton, Ph.D., study investigator, chief scientific officer and director of Zengen. We are particularly excited by these findings as these data, coupled with abundant evidence of the anti-inflammatory and anti-infective activity of Zengens novel molecules based on alpha-MSH, further validate our research and development efforts in numerous areas including celiac disease. These positive results will be used to guide further advancements toward clinical use of the molecules. The study used human celiac mucosa cells in culture. Researchers collected duodenal biopsy pairs from 53 adult celiac patients (34 untreated patients and 19 celiac patients on a gluten-free diet) and 14 normal subjects and conducted three series of experiments in order to determine: (1) mucosal immunoreactivity for alpha-MSH and melanocortin receptors (MCRs), and gene expression of alpha-MSH precursor pro-opiomelanocortin and MCRs; (2) alpha-MSH and inflammatory cytokine production by duodenal specimens in vitro, and the influence of synthetic alpha-MSH on such cytokine production, and; (3) the influence of stimulation with gliadin on alpha-MSH and cytokine production in vitro and the effect of alpha-MSH on gliadin-stimulated cytokine production. Results suggest a localized anti-inflammatory influence based on alpha-MSH and its receptors: duodenal mucosa showed evidence of alpha-MSH and two of its receptor subtypes, MC1R and MC5R. Further, alpha-MSH and MC1R immunoreactivity was more intense in cell specimens from celiac patients and release of interleukin 6 (a lymphokine that stimulates the inflammatory response) from gliadin-stimulated duodenal mucosa was inhibited by synthetic alpha-MSH. Patients suffering from celiac disease currently have no medical options beyond a lifetime adherence to a strict, gluten-free diet, added Dr. Lipton. Clearly, if we can control the inflammatory responses that are a major part of celiac disease and limit the immunosuppression, this could lead to the first medical treatment to help the millions worldwide suffering from this genetic disease. Zengens novel molecules were developed from more than 25 years of original research in the US, Europe and Asia on peptide molecules derived from alpha-Melanocyte-Stimulating Hormone (alpha-MSH). James Lipton, Ph.D., Zengens chief scientific officer, chairman of the scientific advisory board and director, and his collaborators first demonstrated that alpha-MSH possesses anti-inflammatory properties and uncovered the specific activity of the carboxy-terminal tripeptide region (C-terminal peptide) of the alpha-MSH peptide. These discoveries led to the development of Zengens proprietary peptide molecules, including CZEN 002, a synthetic octapeptide. Zengen is currently conducting phase I/II clinical trials with CZEN 002 in vaginitis. About Celiac Disease According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH), celiac disease (celiac disease), also known as gluten intolerance, celiac sprue or gluten sensitive enteropathy, affects an estimated one in 250 Americans. Celiac disease is a condition in which there is a chronic reaction to proteins called glutens which causes destruction of the villi in the small intestine, with resulting malabsorption of nutrients. A genetic disease, it may appear at any time in the life of a person with a hereditary predisposition. Celiac disease is often misdiagnosed, symptoms are varied and there is no current medical treatment or cure. Patients who suffer from celiac disease currently have only one alternative -- adherence to a lifetime, gluten-free diet. If left untreated, celiac disease can lead to malabsorption, which, in turn, can lead to malnutrition. Celiac disease is especially serious in children and adolescents, who need adequate nutrition to develop properly. Further, people with celiac disease who dont maintain a strict, gluten-free diet have a greater chance of developing one of several forms of cancer, particularly intestinal lymphoma. Other long-term complications include anemia, diabetes mellitus, hypothyroidism, osteoporosis, seizures and peripheral neuropathy. About Zengen, Inc Zengen, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative products to treat and prevent infection and inflammation through application of its proprietary peptide technologies. Zengens novel molecules offer broad-based anti-infective and anti-inflammatory solutions for multiple diseases and disorders, ranging from yeast infection to transplantation, and have the potential to significantly alter the way these diseases are treated. For more information about Zengen, please visit www.zengen.com. Zengen, Inc. Forward-Looking Statement Disclaimer This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect managements current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors. The company is developing several products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Source: Zengen, Inc.
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